This morning the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) resumed consideration of U.S. engagement in the global response to the current Ebola epidemic by examining ethical issues that arise when conducting research during a public health emergency.
As experts move to accelerate development of drugs and vaccines against Ebola, a debate has emerged over whether these therapies should be evaluated with the placebo randomized control approach. This type of research involves clinical trials in which one group of volunteers receives the actual vaccine or drug candidate and another group receives a placebo.
Many clinicians consider the placebo-control approach to be the gold standard for determining the efficacy of a new treatment. But tension in western Africa today involves how scientists and policy makers should prioritize humanitarian and scientific concerns as they address both the immediate crisis and seek evidence that can be applied to future outbreaks.
Clement A. Adebamowo, B.M., Ch.B., F.W.A.C.S., F.A.C.S., Sc.D., a Professor of Epidemiology and Public Health at the University of Maryland School of Medicine, told members of the Bioethics Commission that the placebo-control approach provides very strong evidence. But Adebamowo, who was closely involved with Nigeria’s Ebola response as chair of Nigeria’s National Health Research Ethics Committee, said Nigerian health authorities have concluded there are instances in which other approaches may be warranted.
“We believe that these things should not be taken as doctrinaire positions,” he said. “That is why the Nigerian ethics committee issued the guidance statement saying we are going allow the use of therapies that have not completed the standard clinical trial development pathway in the context of this epidemic and share the data with all so we can rapidly evaluate the efficacy of these interventions.”
Luciana Borio, M.D., Assistant Commissioner for Counterterrorism Policy and Director of the Office of Counterterrorism and Emerging Threats at the U.S.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.